“AstraZeneca’s sincerity in oncology drives cont. growth"

Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca

“Is devoted to the discovery of next-generation anticancer drugs by identifying unmet needs”

AstraZeneca is known for its ‘sincere attitude’ towards R&D.

 

Not only is the company in the top ranks in terms of its investment amount, but it has also always been at the forefront in terms of R&D-to-Total-revenue ratio as well.

 

In 2021, AstraZeneca’s R&D-to-Total-revenue ratio stood at 26%, the highest in the industry.

 

Due to their invested interest, the company is rarely behind in recognizing new drug development trends.

 

More often, AstraZeneca has led the trend, releasing first-in-class drugs.

 

AstraZeneca developed the antidiabetic SGLT-2 inhibitor ‘Forxiga,’ a drug that has recently been receiving attention for demonstrating cardiovascular benefit, and the oral antiplatelet ‘Brilinta,’ the only contender of Plavix (clopidogrel).

 

Also, 'Crestor (rosuvastatin)’ which had threatened the sales of ‘Lipitor (atorvastatin),’ and the ICS/LABA combination ‘Symbicort’ are also some of AstraZeneca’s well-known products.

 

Building on this solid foundation, AstraZeneca is now busy reinforcing its Oncology pipeline.

 

In addition to the third-generation epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) ‘Tagrisso (osimertinib),’ the company has added the PD-L1 inhibiting immuno-oncology drug ‘Imfinzi (durvalumab)’ to its portfolio.

 

In other words, the company's oncology pipeline is no longer represented by its first-generation EGFR TKI “Iressa (gefitinib).” Dailypharm met with Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca to hear about the company’s oncology drug development.

 

Trained as a clinical oncologist and Ph.D., EVP Galbraith has been leading Oncology R&D at the company for the past 12 years.

 

-Which product were you most deeply involved in developing? I would have to say that I am most fond of Tagrisso.

 

AstraZeneca aspires to become a leader in Oncology.

 

When I joined the company, hormonal treatments such as Faslodex, as well as Iressa were already developed, and Tagrisso was in the development stage.

 

My first work after joining AstraZeneca was to organize the company’s research portfolio.

 

At the time, I suggested that we should focus on products with higher potential rather than products that have less chance of success.

 

This was even before a project name had been coined for the development of Tagrisso, but I believed in the potential of the substance and made the decision to accelerate its development.

 

Many patients who were treated with existing targeted therapies at the time had been developing resistance or intolerance to their treatments.

 

They developed secondary mutations, and the drugs were not binding well in their targeted sites.

 

I saw the potential of Tagrisso in addressing this unmet need.

 

So Tagrisso was first administered to a patient in 2013.

 

The Seoul National University Hospital in Korea also participated in our Phase I clinical trial, and tumor size was reduced in 2 of the 4 patients that were administered Tagrisso at the time.

 

Resistance to existing treatment options -the T790M mutation - is found in around 50% of all EGFR-mutated lung cancer patients.

 

Although we weren’t testing for the T790M mutation at the time, the tumor size reduction in 2 of the 4 patients raised hopes on how the drug targets the T790M mutation and brings therapeutic benefits.

 

I still remember telling the chemist that developed the substance the good news about how promising the substance was.

 

AstraZeneca was able to gain such insight based on solid collaboration with healthcare professionals in Asia.

 

Our collaboration with healthcare professionals in Korea, Japan, and Taiwan greatly contributed to our discovery by helping us secure information on the resistance mechanism in advance.

 

-As you mentioned, AstraZeneca’s oncology pipeline is rising in prominence.

 

The pipeline, which had already existed for a while, seems to be getting stronger.

 

You already own extensive product lines in Respiratory, Cardiovascular, and Endocrinology, does this mean you will be focusing on oncology drugs in the future? That’s not so.

 

Rather than concentrating on either part, we are making efforts to build a balanced portfolio that can cover various treatment areas.

 

Although 40-50% of our R&D budget is being invested in oncology drugs, we also have pipelines in various other treatment areas including Cardiovascular (CV), Renal, Respiratory, Immunology, Vaccines, etc.

 

Oncology drugs do take up much of our interest, but it is not our sole area of interest.

 

We have recently seen reports on how Forxiga, our antidiabetic drug, has significantly improved the risk of cardiovascular death.

 

-It is also impressive that the company collaborated with Asian researchers from early phase trials for Tagrisso.

 

Contrary to how Korea actively attracts Phase III trials, there has been criticism on how global pharmaceutical companies lack investment in early phase trials in Korea.

 

I hope more opportunities will come in the future for Korea to collaborate with AstraZeneca. We are very interested in seeking opportunities in Korea.

 

South Korea has been an innovation hub in developing new drugs for quite a long while and is leading in clinical trials.

 

It is number three in contribution to global oncology clinical trials worldwide.

 

In fact, involvement in the early phase clinical trials is something we have been doing with South Korea for many years and has built on year-on-year.

 

-AstraZeneca’s competitivity has been further reinforced with the addition of the PARP inhibitor Lynparza to the pipeline.

 

On the other hand, your immuno-oncology drug Imfinzi has been showing less impressive performance.

 

Do you believe there is an opportunity for its comeback?

 

We were excited to present data on the first improvement seen in biliary tract cancer for many years with Imfinzi.

 

Biliary tract cancer is quite prevalent in Asia, and the addition of Imfinzi to first-line chemotherapy improved the treatment effect.

 

The Imfinzi combination therapy was approved in the US based on this TOPAZ study, and we look forward to its approval in Japan as well.

 

We also presented data earlier this year for the HIMALAYA study in liver cancer, in which the combination of Imfinzi with ‘Tremelimumab (anti-CTLA4 antibody)’ in a regimen where just one higher dose of Tremelimumab in order to improve the tolerability profile showed an improvement in the long-term survival benefit in liver cancer patients.

 

I hope to hear from the US FDA on an indication based on the HIMALAYA study within the year.

 

In addition, we have also submitted data in the first-line and non-small cell lunger cancer setting for the combination of Imfinzi with Tremelimumab added to chemotherapy.